Associate Engineer (Quality/Regulatory Assurance)

MCI Career Services Pte Ltd; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

Join a leading biomedical company focusing on quality and regulatory compliance for pharmaceutical products. This role involves maintaining the QMS, supporting regulatory compliance across key markets, and requires a background in engineering or life sciences. Strong project management and communication skills are essential for success in this position.

Benefits

Good work-life balance

Close to MRT station

Qualifications

• Understanding of ISO13485 QMS, cGMP regulations.
• Minimum 1 year supervisory experience in QC.
• Diploma holders with 3+ years relevant experience considered.

Responsibilities

• Implement & maintain QMS per ISO13485, FDA standards.
• Assist in product registration and liaison with regulatory agencies.
• Support document control and manage quality audits.

Skills

Project Management

Cross-Team Communication

Mandarin

Education

Degree in Engineering (Mechanical) or Life Sciences

Job description

Join a leading biomedical manufacturing company specializing in sterile pharmaceutical and ophthalmic solutions, serving key markets across Asia Pacific, North America, and Europe. Be part of a dynamic, global organization driving innovation and quality in healthcare.

About the role

You will ensure product life cycle comply with quality & regulatory standards by reviewing validation protocols, managing registrations, renewals and supporting post-market surveillance. Additionally, support the company’s QMS (Quality Management System) and advise on appropriate regulatory procedures requirements and are legally marketed in the relevant countries where required. Strong project management skills and effective cross-team communication are essential.

Job Summary:

• Monthly Salary from S$3000 to S$3500

• Mon- Fri (7.45 am to 4.45 pm)

• Good work-life balance

• Tuas (3 min walk from Tuas Crescent MRT)

Job Responsibilities:

• Participate & assist in the implementation & maintenance of the QMS in accordance with relevant & applicable quality & regulatory requirements – ISO13485, FDA 21 CFR, EU MDD/MDR, cGMP, etc.)

• Participate & assist in the development of QA strategies, recommendations for continual improvements, quality planning in conjunction with the needs of the company

• Participate & assist in product registration, renewal and change notification of products by working with the relevant countries’ regulatory agencies and/or customers & appointed consultants

• Work closely with the countries’ market authorized representatives to maintain & keep track of the latest regulatory requirements and incorporating them into the company’s QMS where applicable

• Maintain & support aspects of QMS such as document control, management reviews, internal/external quality audits, NCR/ CAPA, product complaints & recall and training, including follow-up actions.

Required:

• Minimum Degree in Engineering (Mechanical) or Life Sciences (Pharmacy, Biology, Chemistry)

• Diploma holders with >3 years of relevant experience can be considered

• Understanding of ISO13485 QMS, cGMP and country regulations (SG HSA, US FDA, AUS TGA, CN NMPA, EU MDD/MDR, etc.)

• Read, write & speak Mandarin to liaise with regulatory agencies

• Minimum 1 year supervisory experience in QC may apply for QC Supervisor

Applicants who possess relevant experience for the above responsibilities are most welcome to apply. If you do not possess the above experience, your application will still be considered on individual merits and you may be contacted for other opportunities.

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**We regret to inform that only shortlisted candidates would be notified.

Lee Yu Xian

Registration Number: R25136202

EA Licence No: 06C2859 (MCI Career Services Pte Ltd)